EUA Consultant will help you determine if the EUA is the right path for your device. We will help you to prepare for EUA filing and help you explore the EUA filing process and meet regulatory requirements under the EUA and after the COVID-19 outbreak. Preparation and submission of the EUA: Implementing an Emergency Use Authorization…
Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for…
Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent use and application of Data Standards can reduce costs of…
The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards. The cGMP Injectable Product Manufacturing process is generally the primary place where…
Introduction: Devices exempted under 510(k) state if the device offers safety and is highly effective on the consumers under the FDA. Exempted Devices which get relaxation by 510(k) are classified by the FDA into Class I type, Class II type, and Class III type. There are specific regulations mentioned with each generic type of device.…
Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety. Pharmaceutical Product…
Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic…
Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products. What are combination products? As per FDA’s guidelines,…
After the FDA 510 k submissions, there is a lengthy review process there that is being performed by the team. Also, getting the certification is not a very easy task. For this reason, a brief checklist is here that are needed to be considered so that the submission and certification procedure will get more hassle-free.…
Post marketing surveillance is the process of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. The drugs and medical devices are generally approved on the basis of clinical trials, which involves relatively a number of…